The U.S. Food and Drug Administration has two roles related to its food jurisdiction: (1) ensure food safety and (2) protect against consumer fraud or deception. Over FDA’s 110-year history, the Agency’s focus has oscillated between these two areas. Since the early...
The 21st century has brought us many new technologies that have improved lives, and now AdEchoTech has added one more innovation to the list: MELODY. 75 YEARS after the first sonography was used for medical diagnosis by neurologist Karl Dussick, AdEchoTech has...
The Food Safety Modernization Act’s (FSMA’s) staggered implementation continues with two new compliance events for the animal food industry starting yesterday, September 18, 2017. “Large” Facilities (500 or more employees) must comply with the Hazard Analysis and...
The Microneedling industry developed and flourished without any substantive guidance from FDA other than periodic whack-a-mole enforcement actions. That changed today (Sept. 14, 2017) with FDA issuing a DRAFT guidance with the captivating name: “Regulatory...
The US drug approval process is long and costly, and pharmaceutical development companies pass the extensive costs of research, user fees, and monopoly rent on to American consumers. Essentially, U.S. patients have been...
FDA has begun inspecting U.S. food importers for their compliance with the Foreign Supplier Verification Program (FSVP). The FSVP regulation has a staggered compliance date between May 30, 2017 through July 27, 2020 (depending on the food type and the foreign...
Three experienced regulatory team members from FDAImports.com attended the Florida International Medical Expo (FIME) in Orlando with great success. We had excellent conversations with industry professionals all along the medical device development, production and...
Using the argument that the acceleration of scientific innovation and expansion of global markets require it, the Food and Drug Administration (FDA) is seeking new program models to meet the demands of a changing world. According to FDA, these needs led to the recent...
Healthy is a word that we use every day, but when we use it in terms of food labeling, the word takes on a more important and controversial meaning. In 2015, the FDA issued a warning letter to the KIND company stating that the use of the motto “healthy and tasty” on...
Editor’s Note: On September 29, 2017, FDA proposed to extend the compliance dates for the Nutrition Facts panel final rule to January 1, 2020 for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food...
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